NCT04891705已完成不适用
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 5
- 主要终点
- The study data will be used to support future performance assessments for Artificial Intelligence based algorithms as described by FDA guidance for Computer Assisted Detection and Diagnostic Devices
研究概览
简要总结
This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion. The information will be used to test the performance of Artificial Intelligence (AI) in identification of features associated with the above lung conditions.
详细描述
This is a prospective, observational, multi-center, post-market clinical study. Enrollment will continue (up to a maximum of 500 adult subjects and up to 300 pediatric subjects) until diagnostic LUS exams are acquired for each of the following groups:
Approximately 500 Adult subjects targeting:
- Approximately 175 exams from patients positive for lung consolidation
- Approximately 175 exams from patients positive for pleural effusion
- Approximately 150 exams from patients negative for both conditions
Approximately 300 pediatric subjects targeting:
- Approximately 150 exams from patients positive for lung consolidation
- Approximately 150 exams from patients negative for lung consolidation
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects presenting to the Emergency Department, admitted to the hospital, or seen in the outpatient setting with suspicion of pleural effusion or lung consolidation who received chest imaging to include chest X-ray or CT, or for whom chest X-ray or CT are planned.
- •Suspicion of pleural effusion or lung consolidation may be based upon imaging findings or presentation of symptoms including (but not limited to) dyspnea, hypoxia, tachypnea, rales, or dullness.
- •All attempts should be made for subjects to undergo scanning of 14 lung zones (adults) and 12 lung zones (pediatrics). Attempts should also be made to capture all required lung zones in adults and pediatrics. Instances where all zones cannot be captured need to be documented and reason for inability to scan them provided in EDC. See Section 8.1.3 Lung Ultrasound Exams.
- •Subject is willing to provide informed consent (or assent where age appropriate) to participate in the study. Subjects under 18 years of age require informed consent of a parent or guardian and assent as required by institutional IRB.
- •Weight of subject is greater than or equal to 10 kg.
排除标准
- •Subject has pathology precluding safe and pain-free ultrasound probe placement such as burn, significant soft tissue injury or surgical incisions.
- •Current imprisonment.
- •Pregnancy (self-reported)
- •Subjects with breast implants
- •Prior pleurodesis procedure.
- •History of severe lung disease and home oxygen use
- •Presence of subcutaneous air that precludes imaging
- •Body Mass Index (BMI) > 40
- •Significant scoliosis (Cobb angle ≥ 20 degrees).
- •Pediatric subjects with chronic lung diseases other than asthma.
- •Pediatric subjects on chronic respiratory support (i.e., nasal canula, CPAP, BiPAP, or tracheostomy).
结局指标
主要结局
The study data will be used to support future performance assessments for Artificial Intelligence based algorithms as described by FDA guidance for Computer Assisted Detection and Diagnostic Devices
时间窗: Discharge up to 30 days (Single visit)
次要结局
未报告次要终点
研究者
研究点 (5)
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